510(k) · Cleared
ClearedRelient Navigation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acclarent, Inc. · KAM Cannula, Sinus
Cleared on May 5, 2006 after a 25-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- May 5, 2006
- Review
- 25 days
- Class
- Class I
- Product code
- KAM
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K043445 | Sinus Guide Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…, 2006 ReliENT™ Navigation Device 55 Ol Sinus Guidc Adapter and Calibration Device Class1 21 CFR 874.4420 ENT Manual Surgical Instrument KAM Sinus Guide Catheter (K043445) The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver, The Sinus Guide Adapter is used i… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KAM devicesKAM Cannula, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KAM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KAM
Too few KAM 510(k)s in any year since 2007 to give a median.
Recalls per year · KAM
No recall names KAM since 2007.
Adverse event reports per year · KAM
3in 2016
MAUDE reports naming product code KAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060974: Relient Navigation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060974
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026